ClotTriever XL Catheter AS-0235Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00850291007277), received between Dec 1, 2023 and Feb 27, 2026 — classified as 9 deaths, 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (14 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jul 19, 2024Class IOpen, Classified

   Thrombectomy system catheter instructions for use updated to reduce adverse events due to the following circumstances: 1) Fibrous, firmly adherent, calcified material, or suspected tumor thrombus overloading catheter bag 2) Catheter pulled through internal jugular vein access site or not pulled away from heart; may lead to device entrapment, pulmonary embolism, venous cutdown, abdominal surgery.

   Z-2587-2024 · Root cause: Labeling design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026 A 67-YEAR-OLD PATIENT UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE PATIENT HAD CLOT INT THEIR LEFT LOWER EXTREMITY AS WELL AS THEIR INFERIOR VENA CAVA (IVC). THE PATIENT ALSO HAD A PREEXISTING FILTER IN THEIR IVC. THE PATIENT WAS POSITIONED SUPINE TO REMOVE THEIR IVC FILTER. THE IVC FILTER WAS SUCCESSFULLY REMOVED AT THE START OF THE CASE USING THE PROTRIEVE SHEATH. FOLLOWING THE FILTER REMOVAL, ASPIRATION WAS PERFORMED THROUGH THE PROTRIEVE SHEATH, WHICH REMOVED THROMBUS FROM THE PATIENT'S IVC. THE PROTRIEVE SHEATH WAS THEN REMOVED AND THE PATIENT'S NECK ASSESS SITE WAS CLOSED AND THE PATIENT WAS REPOSITIONED PRONE TO CONTINUE THE PROCEDURE. FOUR THROMBECTOMY PASSES WERE PERFORMED USING THE CLOTTRIEVER XL CATHETER. AFTER THE FOURTH PASS, THE PATIENT BEGAN TO DETERIORATE AND BECAME UNRESPONSIVE. THE SHEATH WAS SECURED AND THE PATIENT WAS REPOSITIONED SUPINE. THE STOKE TEAM WAS CALLED AND THE PATIENT WAS PLACED ON A NON-REBREATHER WITH OXYGEN AT 15 LITERS PER MINUTE. TENECTEPLASE (TNK) WAS ADMINISTERED AND THE PATIENT BECAME RESPONSIVE AND WAS ABLE TO FOLLOW COMMANDS AND MOVE EXTREMITIES. FOLLOWING STABILIZATION, IMAGING DEMONSTRATED FIND

  Patient problems: Stroke/CVA

  MAUDE report 24475507 ↗
• DeathAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WITH PULMONARY EMBOLISM AND THEIR INFERIOR VENA CAVA (IVC) COMPLETELY OCCLUDED WITH THROMBUS WAS ADMITTED TO THE HOSPITAL AND UNDERWENT A THROMBECTOMY. THERE WAS SOME CLOT IN THE LEFT PULMONARY ARTERY, BUT THE PHYSICIAN OPTED TO GO AFTER THE IVC CLOT FIRST. MULTIPLE ASPIRATIONS WERE PERFORMED UNSUCCESSFULLY. A PASS WAS DONE WITH THE CLOTTRIEVER XL CATHETER WHICH RETURNED A BAG FULL OF CHRONIC CLOT AND/OR TUMOR THROMBUS. HOWEVER, ONCE THE CATHETER PULLED, THE PATIENT IMMEDIATELY DETERIORATED. UNFORTUNATELY, THE PATIENT ULTIMATELY EXPIRED.

  Patient problems: Pulmonary Embolism

  MAUDE report 22856443 ↗
• DeathAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 58-YEAR-OLD PATIENT WITH LEFT ILIAC DEEP VEIN THROMBOSIS THAT EXTENDED INTO THE INFERIOR VENA CAVA (IVC), UNDERWENT A THROMBECTOMY WITH THE CLOTTRIEVER XL CATHETER (CTXL). THE PATIENT WAS PLACED PRONE AND EXPRESSED THAT THEY COULD NOT BREATH WELL. THE PATIENT'S O2 WAS MEASURED TO BE 89% AT THIS TIME, SO THE PROCEDURE WAS CONTINUED. DUE TO THE PATIENT'S ELEVATED CREATINE LEVELS, NO COMPUTED TOMOGRAPHY SCAN WAS PERFORMED PRIOR TO THE PROCEDURE, AND NO CONTRAST WAS USED. INTRAVENOUS ULTRASOUND WAS USED AND SHOWED SIGNIFICANT CLOT FROM THE ILIAC INTO THE IVC. NO CLOT CAPTURE WAS USED AND THE CTXL WAS USED TO PERFORM 2 PASSES. BETWEEN THE PASSES, THE PATIENT BEGAN SAYING THEY COULD NOT BREATHE DESPITE THEIR O2 BEING 88%. THE PATIENT WAS PLACED ON A NON-REBREATHER WHICH HELPED IMPROVE THEIR O2. HOWEVER, THE PATIENT WAS ALSO TACHYCARDIC AND BEGAN EXPRESSING CONCERNS OVER BREATHING AGAIN. THE PATIENT ALSO BEGAN TO PUSH HIMSELF UP FROM THE TABLE. THE PATIENT WAS FLIPPED OVER BUT DURING THIS PROCESS, THE PATIENT'S HEART RATE DROPPED AND STOPPED. CARDIOPULMONARY RESUSCITATION WAS PERFORMED FOR 40 MINUTES BUT UNFORTUNATELY, A PULSE WAS NEVER REGAINED.

  Patient problems: Pulmonary Embolism

  MAUDE report 22745205 ↗
• InjuryMar 12, 2025Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Remove; Improper or Incorrect Procedure or Method

  A 76-YEAR-OLD FEMALE PRESENTED TO THE EMERGENCY ROOM WITH LEFT LEG SWELLING AND PAIN. AN ULTRASOUND WAS PERFORMED WHICH REVEALED CLOT EXTENDING FROM THE COMMON FEMORAL VEIN DOWN TO THE POPLITEAL VEIN. A THROMBECTOMY WAS PERFORMED WITH THE INARI CLOTTRIEVER (CT) SYSTEM. THE PATIENT WAS PLACED PRONE, AND ACCESS WAS OBTAINED USING ULTRASOUND. WIRE POSITIONING WAS ACHIEVED, AND THE 13 FR CLOTTRIEVER SHEATH WAS INSERTED IN THE POPLITEAL VEIN. A CT CATHETER WAS USED TO PERFORM 8 PASSES WHICH YIELDED ACUTE CLOT. IMAGING WAS PERFORMED AFTER THIS WHICH REVEALED A DUPLICATE FEMORAL VEIN SYSTEM AND CLOT IN AN ANEURYSMAL SEGMENT IN THE PROXIMAL ILIAC. A CT BOLD WAS THEN USED TO PERFORM 2 PASSES WHICH YIELDED A SMALL AMOUNT OF CLOT. ANOTHER VENOGRAM WAS PERFORMED WHICH SHOWED CLOTS REMAINING IN THE ANEURYSMAL SEGMENT IN THE PROXIMAL ILIAC. THE SHEATH WAS EXCHANGED FOR A 16 FR CT SHEATH AND A CTXL WAS INSERTED. RESISTANCE WAS NOTED WHEN THE TIP OF THE CTXL WAS AT THE CONFLUENCE OF THE INFERIOR VENA CAVA. THE DECISION WAS MADE TO REMOVE CTXL UNDEPLOYED, BUT RESISTANCE WAS AGAIN NOTED DURING REMOVAL. A VENOGRAM WAS PERFORMED WHICH REVEALED EXTRAVASATION IN THE DUPLICATE FEMORAL VEIN. A 7 MM VIABAH

  Patient problems: Vascular Dissection

  MAUDE report 21590200 ↗
• MalfunctionFeb 13, 2025Difficult to Remove; Retraction Problem; Difficult to Remove; Retraction Problem

  ON (B)(6) 2025, A 57-YEAR-OLD FEMALE UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE PATIENT HAD CLOT IN THE SUPRARENAL INFERIOR VENA CAVA (IVC) THAT WAS ESTIMATED TO BE TWO DAYS OLD. THE PATIENT HAD UNDERGONE DVT THROMBECTOMY THE DAY PRIOR ON (B)(6) 2025, WHERE THE INARI FLOWTRIEVER SYSTEM WAS USED TO ATTEMPT TO ASPIRATE THE CLOT, BUT WAS UNSUCCESSFUL. DURING THE DVT THROMBECTOMY ON (B)(6) 2025, THE CLOTTRIEVER XL CATHETER (CT XL) COLLECTION BAG COLLECTED A LARGE AMOUNT OF DENSE CLOT WHICH PREVENTED THE COLLECTION BAG FROM RETRACTING INTO THE CATHETER. THE MEDICAL TEAM ATTEMPTED TO REMOVE THE CT XL AND INTRODUCER SHEATH TOGETHER, HOWEVER THE SHEATH WAS INADVERTENTLY REMOVED, LEAVING THE CT XL IN THE PATIENT'S VESSEL. THE MEDICAL TEAM WAS THEN ABLE TO REMOVE THE CT XL BY PERFORMING AN ADDITIONAL SKIN NICK AND REMOVING THE DEVICE WITH CLAMPS. THE PATIENT DID NOT REQUIRE ADDITIONAL SURGERY AND INTRAVASCULAR ULTRASOUND (IVUS) WAS RUN WHERE IT WAS NOTED THE MAJORITY OF CLOT WAS REMOVED WITH NO VENOUS INJURY. THE PATIENT DID NOT DECOMPENSATE THROUGHOUT THE DURATION OF THE PROCEDURE AND WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21375949 ↗
• DeathJan 29, 2025Difficult to Remove; Use of Device Problem; Difficult to Remove; Use of Device Problem

  THE PATIENT WAS A 27-YEAR-OLD MALE WITH DEEP VEIN THROMBOSIS. THE MAJORITY OF THE PATIENT'S THROMBUS HAD BEEN REMOVED USING A TRIEVER20. IMAGING WAS PERFORMED WHICH REVEALED RESIDUAL CLOTS THE PHYSICIAN CHOSE TO ADDRESS WITH THE CLOTTRIEVER XL CATHETER (CTXL). NO INFERIOR VENA CAVA (IVC) FILTER OR PROTECTION WAS SEEN. THE CTXL WAS USED TO PERFORM A PASS IN THE COMMON FEMORAL VEIN. AFTER REMOVAL AND CLEANING THE BASKET, THE PATIENT'S O2 DROPPED TO THE LOW 90S. AFTER A COUPLE OF DEEP BREATHS, THE PATIENT'S O2 CAME BACK UP, AND THE PHYSICIAN PERFORMED ANOTHER PASS. AFTER THIS OCCURRED, THE PATIENT'S O2 DROPPED AGAIN BUT MORE SIGNIFICANTLY. A CODE WAS CALLED, AND THE PATIENT WAS FLIPPED ONTO HIS STRETCHER. MULTIPLE ROUNDS OF RESUSCITATION MEDICATIONS WERE ADMINISTERED TO THE PATIENT. RESUSCITATION EFFORTS (CPR) WERE CONTINUED FOR 45 MINUTES BEFORE THE CASE WAS CALLED AND THE PATIENT EXPIRED.

  Patient problems: Pulmonary Embolism

  MAUDE report 21266451 ↗
• DeathDec 26, 2024Difficult to Remove; Use of Device Problem; Difficult to Remove; Use of Device Problem

  THE PATIENT WAS A 51-YEAR-OLD FEMALE WITH LOWER LEFT EXTREMITY DEEP VEIN THROMBOSIS (DVT). AN ULTRASOUND SHOWED ACUTE DVT. NO CHEST COMPUTED TOMOGRAPHY SCAN WAS PERFORMED TO CHECK FOR PRE-EXISTING PULMONARY EMBOLISM (PE). ACCESS AND WIRE POSITIONING WERE OBTAINED WITHOUT ISSUE. VENOGRAMS REVEALED OCCLUSIVE DVT IN THE LEFT POPLITEAL WITH NO OUTFLOW TO THE INFERIOR VENA CAVA (IVC). THE RIGHT POPLITEAL WAS OPEN EXCEPT FOR A SMALL AMOUNT OF THROMBUS AT THE PROXIMAL COMMON ILIAC. THE CLOTTRIEVER SHEATH, 16 FR WAS PLACED IN THE RIGHT POPLITEAL AND THE CLOTTRIEVER SHEATH, 13 FR WAS PLACED IN THE LEFT POPLITEAL. THE PLAN WAS TO USE THE CLOTTRIEVER XL CATHETER (CTXL) TO CLEAR THE IVC AND FOR THE CLOTTRIEVER BOLD CATHETER (CT BOLD) TO CLEAR THE ILIAC ON THE RIGHT. CT BOLD WOULD THEN BE USED TO CLEAN THE LEFT AT THE LOWER LEFT EXTREMITY. THE 1ST PASS WITH THE CTXL RESULTED IN A COLLAPSED CORING ELEMENT AT THE RIGHT COMMON ILIAC. THE PATIENT NOTICED SIGNIFICANT PAIN AND THE PHYSICIAN FELT RESISTANCE. THE CORING ELEMENT WAS SLIGHTLY SHEATHED INTO THE CATHETER AND THE UNIT WAS MOVED UNTIL RESISTANCE WAS MET AGAIN. THE CORING ELEMENT WAS PULLED FURTHER INTO THE OUTER CATHETER WHICH ALLOWED THE UN

  Patient problems: Pulmonary Embolism

  MAUDE report 21020928 ↗
• MalfunctionDec 11, 2024Difficult to Remove; Retraction Problem; Difficult to Remove; Retraction Problem

  A 46-YEAR-OLD FEMALE ARRIVED TO THE HOSPITAL WITH A MASSIVE PULMONARY EMBOLISM AND WAS GIVEN 100 MG OF TPA. IMAGING PERFORMED WHEN THE PATIENT ARRIVED REVEALED CLOT IN THE RIGHT MAIN PULMONARY ARTERY, INFERIOR VENA CAVA (IVC), CLOT ABOVE THE RENAL VEINS, AND RENAL VEIN CLOT. A THROMBECTOMY WAS PERFORMED WITH INARI DEVICES 2 DAYS AFTER THE PATIENT'S INITIAL ARRIVAL. IMAGING CONFIRMED CLOT REMAINED IN THE RIGHT MAIN PULMONARY ARTERY, BUT IT WAS UNCLEAR IF THERE WAS IVC CLOT. IMAGING ALSO REVEALED RIGHT HEART STRAIN, BUT BOTH LEGS WERE FREE FROM DEEP VEIN THROMBOSIS (DVT). THE PHYSICIAN DECIDED TO TREAT THE SUSPECTED IVC CLOT PRIOR TO THE PE. FENTANYL WAS GIVEN AND A VENOGRAM WAS PERFORMED WHICH CONFIRMED IVC CLOT. THE CLOTTRIEVER XL CATHETER (CTXL) WAS CHOSEN TO ADDRESS THE IVC CLOT DUE TO THE SIZE OF THE THROMBUS. THE CTXL'S 1ST PULL REMOVED A SMALL AMOUNT OF CHRONIC THROMBUS. THE 2ND AND 3RD ATTEMPTS DID NOT YIELD CLOT. ANOTHER VENOGRAM WAS PERFORMED WHICH REVEALED LARGE THROMBUS REMAINED IN THE IVC, SUPRARENAL, AND RENAL VEINS. THE 4TH PULL REMOVED A LARGE CHRONIC CLOT. THIS OCCLUDED THE CLOTTRIEVER 16 FR SHEATH, AND THE SHEATH HAD TO BE REMOVED TO PULL THE CTXL OUT OF THE GROIN.

  Patient problems: Cardiac Arrest

  MAUDE report 20905184 ↗
• MalfunctionNov 26, 2024Difficult to Remove; Retraction Problem; Difficult to Remove; Retraction Problem

  ON (B)(6) 2024, A 65-YEAR-OLD MALE UNDERWENT A DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE CLOT AGE WAS ESTIMATED AT SEVEN DAYS. DURING THE THROMBECTOMY, AFTER THE FIFTH PASS USING A CLOTTRIEVER XL CATHETER (CT XL), THE CATHETER BECAME STUCK IN THE SHEATH WHILE ATTEMPTING TO REMOVE THE CT XL CATHETER FROM THE PATIENT. THE PHYSICIAN WAS ABLE TO REMOVE THE CT XL AND THE SHEATH TOGETHER WITHOUT INJURY TO THE PATIENT. ONCE THE DEVICES WERE REMOVED FROM THE PATIENT, THE CT XL WAS ABLE TO BE REMOVED FROM THE SHEATH, HOWEVER THE CORING ELEMENT AND BASKET WERE THEN UNABLE TO BE RESHEATHED INTO THE CT XL DELIVERY CATHETER. A CLOTTRIEVER BOLD CATHETER WAS USED TO COMPLETE THE CASE WITHOUT FURTHER ISSUES, AND IT WAS ESTIMATED THAT 100% OF THE CLOT WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20785507 ↗
• InjuryNov 12, 2024Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  A 66-YEAR-OLD FEMALE UNDERWENT A THROMBECTOMY WITH THE INARI CLOTTRIEVER XL CATHETER (CTXL) TO ADDRESS HER DEEP VEIN THROMBOSIS (DVT). THE PATIENT HAD LONG-STANDING CHRONIC CLOT. TWO PULLS WERE PERFORMED DURING WHICH THE CTXL REMOVED ONLY MINIMAL CLOT. ON THE THIRD PULL, THE CTXL BECAME STUCK AT THE ILIAC ZONE. THE PHYSICIAN WAS UNABLE TO MOVE THE CATHETER, AND DURING ATTEMPTS TO FREE IT, THE INTRI24 SHEATH CAME OUT OF THE PATIENT'S BODY. AFTER 45-MINUTES, THE PHYSICIAN DECIDED TO CUT DOWN THE FEMORAL VEIN. DESPITE THE VENOUS CUTDOWN, THE DEVICE WAS STILL STUCK IN THE ILIAC SO ANOTHER CUTDOWN WAS PERFORMED IN THE ILIAC REGION. THE CORING ELEMENT HAD TO BE CUT TO MANUALLY EXTRACT THE CLOT THAT WAS TRAPPED WITHIN. THE REMOVED CLOT APPEARED CHRONIC AND WAS WELL ORGANIZED. ADDITIONALLY, BLOOD WAS TRANSFUSED TO THE PATIENT DURING THE PROCEDURE. THERE WAS DAMAGE TO THE EXTERNAL ILIAC VEIN AND A TEAR AT THE END OF THE INFERIOR VENA CAVA INTO THE ILIAC. POST-PROCEDURE FOLLOW UP CONFIRMED THE PATIENT IS RECOVERING AND STABLE. IN FOLLOWING UP WITH THE PHYSICIAN THEY INDICATED THE CT XL EFFECTIVELY REMOVED THE THROMBUS FROM THE IVC, THOUGH THE SIZE OF THE CLOT PREVENTED COMPLETE REMOVAL.

  Patient problems: Perforation of Vessels; Vascular Dissection

  MAUDE report 20670038 ↗
• InjuryAug 23, 2024Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  AN INDIVIDUAL WITH INFERIOR VENA CAVA (IVC) AND EXTERNAL ILIAC DEEP VEIN THROMBOSIS (DVT) UNDERWENT A THROMBECTOMY WITH THE CLOTTRIEVER XL CATHETER (CTXL). INTRAVASCULAR ULTRASOUND WAS PERFORMED TO CONFIRM THE THROMBUS LOCATION AND THE SIZE OF THE POPLITEAL VEIN AND IVC. THERE WAS A SMALL CLOT IN THE EXTERNAL ILIAC, BUT THE MAJORITY OF THE CLOT BURDEN WAS IN THE INFRARENAL AREA OF THE IVC. THE POPLITEAL MEASURED 10 MM WHICH IS THE MINIMUM SIZE FOR USAGE OF THE CTXL AND THE IVC MEASURED APPROXIMATELY 20 MM. DURING THE FIRST PASS, THE CTXL ENGAGED CLOT BUT WHEN THE CTXL WAS BROUGHT INTO THE SHEATH, THE DISTAL END OF THE CATHETER BECAME STUCK BEFORE ENTERING THE CLOTTRIEVER 16FR SHEATH. THE PHYSICIAN ATTEMPTED TO REMOVE IT BUT WAS ULTIMATELY UNSUCCESSFUL. THE DISTAL END WAS OVERFILLED WITH CLOT AND WAS TOO BIG TO REMOVE. THE VASCULAR TEAM WAS CALLED IN AND A CUTDOWN WAS PERFORMED TO REMOVE THE CATHETER FROM THE BODY. THE PROCEDURE UNFORTUNATELY RESULTED IN A SMALL SEGMENT OF VESSEL BEING DAMAGED WHEN THE CTXL WAS RETRACTED. A GORE VIABAHN STENT WAS SUTURED TO THE PATIENTS' POPLITEAL VEIN.

  Patient problems: Device Embedded In Tissue or Plaque; Great Vessel Perforation; Vascular Dissection

  MAUDE report 20052407 ↗
• InjuryAug 21, 2024Difficult to Remove; Use of Device Problem; Difficult to Remove; Use of Device Problem

  A MALE PATIENT UNDERWENT A THROMBECTOMY WITH THE CLOTTRIEVER XL CATHETER (CTXL). ACCESS WAS OBTAINED IN THE RIGHT INTERNAL JUGULAR AND THE PROTRIEVE SHEATH WAS PLACED. TWO PASSES WERE PERFORMED WHICH REMOVED CLOT BURDEN. HOWEVER, ON THE THIRD PASS THE CTXL BECAME OVERLOADED AND THE MID TO DISTAL PORTION OF THE COLLECTION BAG BECAME STUCK IN THE PROTRIEVE BASKET. A PROTRIEVE ASPIRATION WAS PERFORMED AND THE PROTRIEVE WAS REMOVED WITH THE CTXL WHILE UNDER ASPIRATION. THE PATIENT THEN BEGAN TO DECOMPENSATE WITH A DROP IN THEIR OXYGEN SATURATION AND HEART RATE. CHEST COMPRESSIONS WERE PERFORMED, AND THE PATIENT WAS PREPPED FOR A PULMONARY EMBOLISM THROMBECTOMY. A CODE WAS CALLED WITH ADDITIONAL CHEST COMPRESSIONS. THE PATIENT WAS AGITATED AND BEGAN MOVING WHICH LED TO ANESTHESIA TO INTUBATE THE PATIENT. CROSSING THE RIGHT HEART WAS DIFFICULT DUE TO THE CHEST COMPRESSIONS BUT EVENTUALLY AN ASPIRATION WAS PERFORMED IN THE RIGHT PULMONARY ARTERY. A LARGE CLOT BURDEN WAS ASPIRATED WHICH WAS ACUTE-ON-CHRONIC. THE PROCEDURE CONTINUED AND ONE MODEST SIZED CLOT WAS REMOVED FROM THE LEFT PULMONARY ARTERY. FINAL IMAGING REVEALED THAT BOTH LOBES FILLED COMPLETELY. THE PATIENT WAS PLACED ON EXTRAC

  Patient problems: Pulmonary Embolism

  MAUDE report 20017755 ↗
• DeathJun 13, 2024Difficult to Remove; Use of Device Problem; Difficult to Remove; Use of Device Problem

  THE PATIENT WAS A 44-YEAR-OLD FEMALE WITH DEEP VEIN THROMBOSIS AND CLOT WITHIN THE INFERIOR VENA CAVA (IVC). ADDITIONALLY, THE PATIENT HAD STAGE 4 BRAIN CANCER AND HAD BEEN UNDERGOING CHEMOTHERAPY WITH THE ADDITION OF A PRIOR OPERATION RELATED TO THE CANCER. A THROMBECTOMY WAS PERFORMED WITH A NON-INARI DEVICE TO ADDRESS THE PATIENT'S CLOT, BUT LITTLE CLOT WAS EXTRACTED AND MOST OF THE ILIAC CLOT WAS PUSHED FORWARD INTO THE IVC WHERE THERE WAS A PRE-EXISTING FILTER IN PLACE. THE PROCEDURE WAS ABORTED AFTER SIGNIFICANT BLOOD LOSS AND HEMODYNAMIC DECOMPENSATION OCCURRED. A SECOND THROMBECTOMY WAS THEN SCHEDULED WITH A PLAN TO USE THE INARI PROTRIEVE SHEATH FROM THE INTERNAL JUGULAR AND ASPIRATING USING THE TRIEVER20 (T20) AND TRIEVER16 CURVE (T16C). THE PROCEDURE WAS CONDUCTED 6 DAYS AFTER THE INITIAL INTERVENTION DUE TO THE PATIENT'S POOR HEMODYNAMICS AND VITALS. ACCESS AND WIRE POSITIONING WERE OBTAINED BUT A PRE-PROCEDURAL ANGIOGRAM WAS NOT PERFORMED. THE T20 WAS ADVANCED OVER THE WIRE AND PLACED WITHIN THE FILTER. FOUR ASPIRATIONS WERE PERFORMED WHICH RESULTED IN MINIMAL CLOT EXTRACTED. AN ANGIOGRAM WAS PERFORMED AT THIS TIME WHICH CONFIRMED THE POSITION OF THE CLOT BURDEN. A T16

  Patient problems: Pulmonary Embolism

  MAUDE report 19531317 ↗
• DeathMay 20, 2024Entrapment of Device; Difficult to Remove; Improper or Incorrect Procedure or Method; Entrapment of Device; Difficult to Remove; Improper or Incorrect Procedure or Method

  A 49-YEAR-OLD MALE WITH RENAL CELL CARCINOMA TUMOR, WAS GIVEN A 50% SURVIVAL RATE OVER THE NEXT 90 DAYS. THE PATIENT HAD DEEP VEIN THROMBOSIS (DVT) CLOT WHICH EXTENDED FROM THE BILATERAL POPLITEAL INTO THE INFERIOR VENA CAVA (IVC) WITH TUMOR THROMBUS EXTENDING FROM THE RIGHT RENAL VEIN. THE CASE BEGAN WITH THE PATIENT IN A SUPINE POSITION. ACCESS WAS OBTAINED WITHOUT ISSUE AND THE PROTRIEVE SHEATH WAS PLACED IN THE INTERNAL JUGULAR AND SECURED WITH A TEGADERM. A CLOTTRIEVER SHEATH 16FR., WAS PLACED IN BOTH POPLITEAL VEINS. THE CLOTTRIEVER BOLD CATHETER WAS ADVANCED INTO POSITION ON THE RIGHT AND SIX PASSES WERE PERFORMED WITH AN ADDITIONAL FOUR ASPIRATIONS. THIS REMOVED A LARGE AMOUNT OF THROMBUS WHICH HAD EXTENDED FROM THE FEMORAL VEIN INTO THE ILIAC. THE PHYSICIAN SWITCHED TO THE LEFT SIDE AND FOUR PASSES WERE PERFORMED WHICH ALSO YIELDED A LARGE CLOT HAUL. THE PHYSICIAN THEN MOVED TO THE IVC AND PERFORMED FOUR PASSES AND FIVE ASPIRATIONS WITH THE CLOTTRIEVER XL CATHETER (CTXL) WHICH REMOVED CHRONIC CLOT. A VENOGRAM WAS THEN PERFORMED WHICH REVEALED THROMBUS STILL PRESENT IN THE IVC CONFLUENCE. THE PHYSICIAN ELECTED TO MOVE TO MORE AGGRESSIVE PULLS WITH THE CTXL FURTHER INTO THE

  Patient problems: Cardiovascular Dysfunction/Insufficiency; Pulmonary Embolism

  MAUDE report 19353756 ↗
• DeathMay 8, 2024Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  A 39-YEAR-OLD FEMALE PATIENT REPORTED FEELING UNWELL AND SOUGHT MEDICAL ATTENTION. IMAGING REVEALED EXTENSIVE AND OCCLUSIVE ILIOCAVAL DEEP VEIN THROMBOSIS (DVT) AND THE PATIENT WAS SCHEDULED TO UNDERGO A DVT THROMBECTOMY USING INARI DEVICES. THE CLOT AGE WAS ESTIMATED AT 10 DAYS. PRIOR TO THE PROCEDURE, THE PATIENT WAS PLACED IN THE SUPINE POSITION AND GIVEN LOCAL ANESTHESIA WITH SEDATION. THE PROTRIEVE SHEATH WAS PLACED AND A TRIEVER20 (T20) WAS PLACED THROUGH THE PROTRIEVE. THREE ASPIRATIONS WERE PERFORMED STARTING FROM THE LOCATION OF THE RENAL VEINS AND MOVING DOWN WITH SUBSEQUENT ASPIRATIONS. THE ASPIRATED BLOOD WAS FILTERED THROUGH THE FLOWSAVER WHICH YIELDED SIGNIFICANT CHRONIC FIBROTIC CLOT. A PASS WAS THEN PERFORMED WITH THE CLOTTRIEVER XL CATHETER (CTXL) WHICH ONLY REMOVED MINIMAL CLOT. FOUR PASSES WERE THEN PERFORMED WITH THE CLOTTRIEVER BOLD STARTING FROM THE RIGHT EXTERNAL ILIAC VEIN. SUBACUTE-CHRONIC CLOT WAS REMOVED FROM THESE PASSES. A VENOGRAM WAS PERFORMED WHICH DEMONSTRATED IMPROVEMENT IN FLOW, BUT THROMBUS REMAINED IN THE INFERIOR VENA CAVA. THE PHYSICIAN DECIDED TO RETRACT THE CTXL TOWARDS THE PROTRIEVE; HOWEVER, SIGNIFICANT RESISTANCE WAS ENCOUNTERED, AND THE

  Patient problems: Cardiovascular Dysfunction/Insufficiency; Pulmonary Embolism

  MAUDE report 19274173 ↗
• InjuryApr 2, 2024Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  A 75-YEAR-OLD MALE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH LOWER LEFT EXTREMITY SWELLING WHERE ULTRASOUND REVEALED ILIOFEMORAL DEEP VEIN THROMBOSIS (DVT). THE PATIENT WAS SCHEDULED FOR A THROMBECTOMY ON (B)(6) 2024 WITH THE INARI CLOTTRIEVER THROMBECTOMY SYSTEM. THE CLOT AGE WAS ESTIMATED AT 3 DAYS. THE BILATERAL POPLITEAL VEINS WERE PREPPED AND A VENOGRAM REVEALED CLOT EXTENDING FROM THE LEFT FEMORAL VEIN TO THE INFERIOR VENA CAVA (IVC) AND EXTENDING TO THE RENAL VEINS. THE PHYSICIAN ELECTED TO USE THE INARI INTRI24 SHEATH IN THE LEFT POPLITEAL VEIN AND ADVANCED THE TRIEVER20 INTO POSITION. THIS WAS USED TO PERFORM ASPIRATIONS THAT YIELDED A LARGE ACUTE CLOT. THE PHYSICIAN THEN SWITCHED TO THE CLOTTRIEVER XL CATHETER (CTXL) TO ADDRESS THE CLOT PRESENT IN THE IVC. ONE PASS WAS PERFORMED DESPITE EXPERIENCING SOME RESISTANCE THROUGH THE COMMON ILIAC VEIN, BUT THE CTXL WAS RETRIEVED WITH NO ISSUES. HOWEVER, DURING RETRIEVAL OF THE SECOND PASS, THE CTXL CATHETER WOULD NOT PASS THROUGH THE ILIAC SEGMENT WITH THE COLLECTION BAG COLLAPSED. IN ORDER TO ADDRESS THIS THE CTXL WAS OPENED JUST ABOVE THE CONFLUENCE AND A TRIEVER24 (T24) WAS TRACKED FROM THE CONTRALATERAL SIDE TO ASPI

  Patient problems: Cardiovascular Dysfunction/Insufficiency; Pulmonary Embolism

  MAUDE report 19029191 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO RECENTLY UNDERWENT A THROMBECTOMY ON (B)(6) 2024 TO ADDRESS HER PULMONARY EMBOLISM (PE) WAS SCHEDULED FOR A THROMBECTOMY ON (B)(6) 2024 WITH THE INARI CLOTTRIEVER THROMBECTOMY SYSTEM TO ADDRESS A LEFT LOWER EXTREMITY DEEP VEIN THROMBOSIS (DVT) (WHICH WAS NOT ADDRESSED DURING HER PREVIOUS PE THROMBECTOMY). THE PRIOR PE THROMBECTOMY (PERFORMED USING INARI DEVICES) WAS UNEVENTFUL AND THE CASE PLAN WAS TO ADDRESS THE PE FIRST AND SCHEDULE THE DVT THROMBECTOMY AT A LATER DATE. THE CLOT AGE WAS ESTIMATED AT 30 DAYS. THE PATIENT WAS PLACED IN A SUPINE POSITION AND THE INTRAJUGULAR VEIN WAS ACCESSED WITH AN INARI PROTRIEVE. THE INARI CLOTTRIEVER XL CATHETER (CTXL) WAS THEN INTRODUCED, AND 3 PASSES WERE PERFORMED WHICH REMOVED A SUBSTANTIAL AMOUNT OF CLOT. THE PROTRIEVE WAS SECURED PRIOR TO THE PASSES BUT DID RETRACT APPROXIMATELY 2 INCHES DURING THE PROCEDURE. THE PROTRIEVE WAS RE-POSITIONED AND ONE MORE PASS WAS PERFORMED WITH THE CTXL. A VENOGRAM WAS PERFORMED WHICH REVEALED THAT FULL PATENCY WAS RESTORED. THE PROCEDURE WAS CONCLUDED, AND THE ACCESS SITE WAS CLOSED. UNFORTUNATELY, THE PATIENT BEGAN TO DECOMPENSATE AND IMAGING REVEALED CLOT IN THE RIGHT PULMONARY ARTE

  Patient problems: Cardiovascular Dysfunction/Insufficiency; Hypoxia; Pulmonary Embolism; Tachycardia

  MAUDE report 18858216 ↗
• DeathFeb 29, 2024Entrapment of Device; Entrapment of Device

  A 71-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF BREAST CANCER PRESENTED TO THE EMERGENCY DEPARTMENT WITH WORSENING ABDOMINAL PAIN AND BLOODY STOOL. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED WHICH REVEALED INFERIOR VENA CAVA (IVC) THROMBUS FROM THE RENAL VEIN EXTENDING DOWN TO THE CONFLUENCE. THE CLOT AGE WAS ESTIMATED AT 2 DAYS. THE PATIENT WAS SCHEDULED FOR A THROMBECTOMY ON (B)(6) 2024 USING THE INARI CLOTTRIEVER THROMBECTOMY SYSTEM. AFTER IMAGING WAS PERFORMED, THE CLOTTRIEVER (CT) SHEATH 16 FR WAS PLACED. ACCESS AND WIRE POSITIONING WERE OBTAINED WITHOUT ISSUE. THE CLOTTRIEVER XL (CTXL) CATHETER WAS ADVANCED INTO PLACE WITH THE BULLET TIP PLACED PROXIMAL TO THE THROMBUS. A SINGLE PASS WAS PERFORMED WHEN THE PATIENT REPORTED EXPERIENCING ABDOMINAL PAIN. THE PHYSICIAN ATTEMPTED TO REMOVE THE CTXL CATHETER FROM THE CT SHEATH BUT WAS UNABLE TO. FLUOROSCOPY REVEALED THE CORING ELEMENT WAS WITHIN THE CT SHEATH, BUT THE PROXIMAL ASPECT OF THE BAG WAS FULL WITH THROMBUS AND APPEARED TO BE EXTENDING OUT OF THE SHEATH FUNNEL. VARIOUS ATTEMPTS WERE MADE TO REMOVE THE CTXL (RE-SHEATHING THE CTXL WITH THE OUTSIDE CATHETER PORTION, ADVANCING THE CATHETER BACK PROXIMALLY, AND REMOVING BOTH

  Patient problems: Abdominal Distention; Abdominal Pain; Great Vessel Perforation; Low Blood Pressure/ Hypotension

  MAUDE report 18805241 ↗
• DeathJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS AN 82-YEAR-OLD MALE WITH A HISTORY OF DEEP VEIN THROMBOSIS (DVT). THE PATIENT HAD AN INFERIOR VENA CAVA (IVC) FILTER PLACED A FEW WEEKS PRIOR. THE PATIENT HAD BEEN EXPERIENCING RIGHT LOWER EXTREMITY PAIN AND SWELLING AND THROMBUS WAS FOUND EXTENDING FROM THE IVC FILTER DOWN TO THE RIGHT PERONEAL VEIN. CLOT WAS ALSO PRESENT IN THE LEFT COMMON ILIAC VEIN (LCIV). A VENOGRAPHY CONFIRMED THE PRESENCE OF THROMBUS BELOW THE KNEE IN THE TIBIO-PERONEAL VEIN UP TO AND INCLUDING THE IVC FILTER. THE PATIENT WAS SCHEDULED FOR THROMBECTOMY WITH THE INARI CLOTTRIEVER THROMBECTOMY SYSTEM. THE PROTRIEVE SHEATH WAS PLACED IN THE RIGHT INTRAJUGULAR AND SECURED WITH AN ANCHOR AT THE SKIN. A HEPARIN BOLUS WAS ADMINISTERED. THE IVC FILTER WAS THEN REMOVED. ACCESS AND WIRE POSITIONING WERE OBTAINED WITHOUT ISSUE. THE CLOTTRIEVER XL CATHETER (CTXL) WAS ADVANCED, AND A PASS WAS PERFORMED IN THE DISTAL IVC. THIS REMOVED SIGNIFICANT CLOT BURDEN. A SECOND PASS WAS PERFORMED MORE DISTALLY WHICH REMOVED SOME ADDITIONAL CLOT. AN ASPIRATION WAS ALSO PERFORMED USING THE PROTRIEVE SHEATH. AS THE CTXL WAS BEING PREPARED FOR ANOTHER PASS THE PATIENT BECAME UNRESPONSIVE AND HAD PINPOINT PUPILS. UPON VI

  Patient problems: Asystole; Bradycardia; Cardiac Arrest; Low Blood Pressure/ Hypotension; Low Oxygen Saturation; Pulmonary Embolism

  MAUDE report 18490212 ↗
• InjuryDec 1, 2023Difficult to Remove; Difficult to Remove

  A PATIENT WITH DEEP VEIN THROMBOSIS (DVT) UNDERWENT A THROMBECTOMY WITH INARI DEVICES. IMAGING REVEALED A TUMOR THROMBUS THAT EXTENDED FROM THE RIGHT ATRIUM ALL THE WAY TO THE INFERIOR VENA CAVA (IVC) AND TO THE MID-FEMORAL VEIN ON THE LEFT LEG. THE CLOT AGE WAS ESTIMATED AT 100 DAYS. THE INTR24 SHEATH AND TRIEVER24 WERE INITIALLY USED TO ASPIRATE THROMBUS FROM THE RIGHT ATRIUM (RA). SEVERAL ASPIRATIONS WERE PERFORMED BEFORE THE PHYSICIAN REALIZED THAT THE THROMBUS WAS WALL-ADHERENT, AND ASPIRATIONS WOULD NOT BE EFFECTIVE. THE DECISION WAS THEN MADE TO USE THE CLOTTRIVER XL CATHETER (CTXL). A PASS WAS PERFORMED WHICH REMOVED TUMOR THROMBUS FROM THE RA. THE INTRI24 SHEATH WAS SWAPPED WITH A PROTRIEVE SHEATH SO THE CTXL COULD BE USED IN THE IVC. THE CTXL WAS DEPLOYED, AND A PASS WAS PERFORMED. A SIGNIFICANT AMOUNT OF TUMOR THROMBUS WAS REMOVED USING THE COLLECTION BAG. UPON ATTEMPTING TO REMOVE THE CTXL FROM THE PROTRIEVE SHEATH, THE DEVICE BECAME OVERLOADED WITH TUMOR/CLOT MATERIAL AND WAS UNABLE TO BE REMOVED THROUGH THE SHEATH. AFTER MULTIPLE ATTEMPTS TO REMOVE THE DEVICE USING EXCESSIVE FORCE AND OVER SHEATHING, THE PHYSICIAN ELECTED TO PERFORM A VENOUS CUT-DOWN. A CUT-DOWN WAS P

  Patient problems: Device Embedded In Tissue or Plaque; Vascular Dissection

  MAUDE report 18253128 ↗